Increasing Private Payer and Medicare Coverage of Circulating Tumor DNA Tests: What’s at Stake?
Authors: Mariana P. Socal
Journal: Journal of the National Comprehensive Cancer Network (2023)

I n their study, "Private Payer and Medicare Coverage Policies for Use of Circulating Tumor DNA Tests in Cancer Diagnostics and Treatment," in this issue, Douglas et al 1 have examined coverage policies for circulating tumor DNA (ctDNA) tests among private payers in the United States and the Medicare program.ctDNA tests have been increasingly used in clinical practice to select targeted therapy, identify disease progression, and measure minimal residual disease after treatment.In addition, ctDNA tests represent diagnostic options for cases in which tissue biopsy is unavailable or contraindicated.The examination of coverage policies for ctDNA tests helps inform the broader question of how new and emerging technologies are incorporated by payers in the United States, a topic that has been the focus of recent regulatory and legislative initiatives.In January 2021, CMS published a final rule establishing a pathway to expedite access to innovative devices for Medicare beneficiaries.This was called the "Medicare Coverage of Innovative Technology" (MCIT) pathway. 2 Under the MCIT, new and innovative medical devices designated as part of the FDA's Breakthrough Devices Program would be automatically granted nationwide coverage by the Medicare program for 4 years starting on the date of FDA market authorization (or on a date up to 2 years after the FDA market authorization at the request of the device manufacturer). 2 At the end of the 4-year coverage period, CMS would determine whether to issue a national coverage determination or to leave it for local Medicare administrator contractor (MAC) to issue local coverage decisions.This rule would have granted immediate nationwide Medicare coverage to the 2 ctDNA tests currently commercially available, Guardant360 CDx and FoundationOne Liquid CDx, both of which have been designated as part of the FDA's Breakthrough Devices program. 3,4CIT's implementation was delayed, and the rule was ultimately rescinded on November 2021.Among other reasons, the MCIT raised concerns that, once the products were covered, there would be few incentives for device manufacturers to conduct additional studies on their products. 5This is an important concern because the clinical trials used to examine breakthrough devices often enroll patients who are significantly different than the population of Medicare beneficiaries-clinical trial participants are often younger or have fewer comorbidities, for example. 5In this case, without further studies, the evidence about benefits and risks of breakthrough devices among the Medicare population would remain very limited and, after 4 years, CMS would still lack robust information to make informed coverage decisions.It would also be very difficult to rescind coverage after a device had been on the market for 4 years.MCIT's provisions, however, became part of a bill introduced in March 2023 in the House of Representatives with bipartisan support: H.R. 1691, the "Ensuring Patient Access to Critical Breakthrough Products Act" of 2023.Meanwhile, CMS has continued to work on options to expedite Medicare coverage of new and innovative medical devices, although no final rule has been issued yet. 6In addition, CMS has other mechanisms that help support the expedited coverage of new devices in Medicare, such as a parallel review program in which manufacturers may opt to have CMS and the FDA simultaneously review a new product, and the coverage with evidence development pathway, through which Medicare covers a new product conditionally on collecting additional evidence on the benefits and risks of the product in the Medicare population. 5